<![CDATA[General Background: Ensuring the quality and efficiency of healthcare services remains a fundamental priority in modern medical institutions. Specific Background: The integration of international standards, particularly ISO 9001:2015 and ISO 7101:2023, is essential in establishing robust quality management systems. Knowledge Gap: However, limited comparative analyses exist regarding the applicability and effectiveness of these standards within diagnostic and treatment institutions. Aims: This study aims to develop and implement a tailored "Quality Management System in Medical Institutions" based on both ISO 9001:2015 and ISO 7101:2023, assessing its impact on healthcare service quality and operational performance. Results: The system, comprising five principles and 53 specific requirements, was implemented at the ASMI Clinic, resulting in an increase in compliance from 45% to 75% over the course of 2023, with notable improvements in patient safety and staff competencies. Novelty: Unlike generic quality systems, the proposed model is uniquely adapted to the healthcare context, incorporating specialized principles and structured responsibilities. Implications: Despite challenges such as limited resources and employee adaptation, the findings support the strategic value of customized quality management frameworks in enhancing institutional performance and aligning with international best practices. Highlights: Compares ISO 9001 and 7101 standards in healthcare. Improves service quality and staff performance. Tailored system fits medical regulatory requirements. Keywords: Healthcare Quality, ISO 9001:2015, ISO 7101:2023, Medical Institutions, Quality Management System]]>
